Workshop 4: Adverse Drug Reactions

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Workshop 4.1: Adverse Drug Reactions

|Case Scenario 1 |

|Question |I have just been prescribed Roaccutane( and have been told that I shouldn’t wax my legs. Will this be forever or |

| |is it only for the duration of time that I am on it? |

|What further background |PERSON |MEDICINES |

|information do you need to | | |

|clarify the question and | | |

|minimise the risks when | | |

|advising the caller? | | |

| |Who is asking? |Medicines (name,dose,freq)? |

| |19 year old female – about herself |Roaccutane( 30mg once a day. |

| | |Microgynon 30( . |

| |New or worsening symptoms? | |

| |No symptoms. |Why asking about medicines? |

| | |Would like further explanation of what the specialist |

| |Any allergies/medical conditions? |said. |

| |No allergies. Acne since mid teens. | |

|Gather the further background information BEFORE searching for information. |

|What information sources |eBNF: |

|would you use? |Roaccutane( contains isotretinoin. |

| |Counselling Warn patient to avoid wax epilation (risk of epidermal stripping), dermabrasion, and laser skin |

| |treatments (risk of scarring) during treatment and for at least 6 months after stopping; patient should avoid |

| |exposure to UV light (including sunlight) and use sunscreen and emollient (including lip balm) preparations from |

| |the start of treatment. |

| |Side-effects dryness of skin (with dermatitis, scaling, thinning, erythema, pruritus), epidermal fragility |

| |(trauma may cause blistering), dryness of lips (sometimes cheilitis), dryness of eyes (with blepharitis and |

| |conjunctivitis), dryness of pharyngeal mucosa (with hoarseness), dryness of nasal mucosa (with epistaxis) |

| |Cautions exclude pregnancy before starting (perform pregnancy test 2–3 days before expected menstruation, start |

| |treatment on day 2 or 3 of menstrual cycle)—women must practice effective contraception at least 1 month before, |

| |during, and for at least 1 month after treatment |

| | |

| |eMC – PIL/Roaccutane(: |

| |Possible side effects |

| |Roaccutane can have side effects, though not everybody gets them. The effects often wear off, or stop when |

| |treatment is stopped. Your doctor can help you deal with them. |

| |Skin and hair problems |

| |Very common effects (may affect more than 1 in every 10 people) |

| | |

| |Dryness of the skin, especially of the lips and face; inflamed skin, chapped and inflamed lips, rash, mild itching|

| |and slight peeling. Use a moisturising cream from the start of treatment. |

| |Skin becomes more fragile and redder than usual, especially the face. |

| | |

| |Women who could get pregnant are only prescribed Roaccutane under strict rules, because of the risk of birth |

| |defects (damage to the unborn baby). |

| |These are the rules: |

| |You must only take Roaccutane if you have severe acne that has not got better after any other anti-acne |

| |treatments, including antibiotics and skin treatments. |

| |Your doctor must have explained the risk of birth defects: you understand why you must not get pregnant and what |

| |you need to do to prevent it. |

| |You must have discussed contraception (birth control) with your doctor. They will give you information on |

| |preventing pregnancy. He or she may refer you to a specialist for contraceptive advice. |

| |You must agree to use one or preferably two effective methods of contraception, including condoms or a cap plus |

| |spermicide, for a month before taking Roaccutane, during treatment and for a month afterwards. Before you start |

| |treatment your doctor will ask you to take a pregnancy test, which must be negative. |

| |You must use contraception even if you do not have periods or are not currently sexually active (unless your |

| |doctor decides this is not necessary). |

| |You must accept the need for monthly follow up visits and more pregnancy tests as decided by your doctor. You may |

| |have a test 5 weeks after stopping Roaccutane. You must not get pregnant during treatment and for a month |

| |afterwards. |

| |Your doctor may ask you (or a guardian) to sign a form that confirms that you have been told about the risks, and |

| |that you accept the necessary precautions. |

| |NetDoctor: |

| |You should avoid exposing your skin to intense sunlight or UV light while taking this medicine. You should use a |

| |sunscreen of at least SPF 15 when necessary. |

| |Isotretinoin is likely to make your skin and lips very dry, so it is recommended that you use a moisturiser and |

| |lip balm from the start of treatment. |

| |You should avoid waxing any part of your body while taking isotretinoin, and for at least six months after |

| |stopping treatment, as this could cause stripping of the top layer of skin. Chemical dermabrasion and cutaneous |

| |laser treatment should also be avoided during treatment with isotretinoin and for five to six months after |

| |stopping treatment, as this could cause scarring. |

| |Isotretinoin causes major birth defects (serious malformations of a developing foetus) if taken during pregnancy. |

| |For this reason your doctor will not prescribe the treatment to women who could get pregnant, unless the following|

| |criteria are met: At least one, but preferably two (for example the pill and condoms), effective methods of |

| |contraception must be used at all times to prevent pregnancy. Contraception must start at least four weeks before |

| |starting treatment, be used at all times during treatment and for at least four weeks after stopping treatment, |

| |even if you don't have a period. Your doctor cannot prescribe isotretinoin until you have been using effective |

| |contraception for at least a month and have had a negative pregnancy test. Your doctor is only allowed to |

| |prescribe 30 days supply of isotretinoin at a time. You will need to have a follow-up visit every month, at which |

| |you will have to have a negative pregnancy test before a new prescription can be issued. Five weeks after stopping|

| |treatment you should have a final pregnancy test to make sure you have not fallen pregnant. If you think there is |

| |a chance you could be pregnant, either during treatment, or in the first month after stopping treatment, you must |

| |consult your doctor immediately. |

|What advice would you give? |Well-known side effect of Roaccutane related to the high dose of vitamin A. |

|Or would you refer? | |

| |Avoid waxing any part of the body during therapy with isotretinoin, and for up to six months after stopping |

| |therapy, due to risk of inflammation of the skin (dermatitis) and scarring. |

|Further learning points |

|Isotretinoin, a Vitamin A analogue, is very toxic and may only be prescribed by / under supervision of a consultant dermatologist. It is |

|teratogenic. Women of childbearing age must be fully informed and practice effective contraception. |

Workshop 4.1: Adverse Drug Reactions

|Case Scenario 2 |

|Question |My son has a rash all over his body and is feeling unwell. He has recently started lamotrigine, could this be |

| |causing the rash? |

|What further background |PERSON |MEDICINES |

|information do you need to | | |

|clarify the question and | | |

|minimise the risks when | | |

|advising the caller? | | |

| |Who is asking? |Medicines (name,dose,freq)? |

| |Mother about 8 years old son. |Lamotrigine 5mg each day. |

| | |Sodium Valproate 200mg twice a day. |

| |New or worsening symptoms? |How long been on these, who prescribed them? |

| |Rash – raised red bumps., not bleeding, all over him. |Lamotrigine started about 3 weeks ago by specialist as |

| |Started yesterday evening. He is hot and feels unwell. |sodium valporate not controlling the fits. |

| | | |

| |Any allergies/medical conditions? | |

| |Epilepsy. | |

|Gather the further background information BEFORE searching for information. |

|What information sources |eBNF: |

|would you use? |Skin reactions Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (rarely |

| |with fatalities) have developed especially in children; most rashes occur in the first 8 weeks. Rash is sometimes |

| |associated with hypersensitivity syndrome (see Side-effects, above) and is more common in patients with history of|

| |allergy or rash from other antiepileptic drugs. Consider withdrawal if rash or signs of hypersensitivity syndrome |

| |develop. The CSM has advised that factors associated with increased risk of serious skin reactions include |

| |concomitant use of valproate, initial lamotrigine dosing higher than recommended and more rapid dose escalation |

| |than recommended. |

| |Counselling Warn patients to see their doctor immediately if rash or signs or symptoms of hypersensitivity |

| |syndrome develop |

| | |

| |eMC SPC/ Lamictal: |

| |Undesirable effects |

| |In double-blind, add-on clinical trials, skin rashes occurred in up to 10% of patients taking lamotrigine and in |

| |5% of patients taking placebo. The skin rashes led to the withdrawal of lamotrigine treatment in 2% of patients. |

| |The rash, usually maculopapular in appearance, generally appears within eight weeks of starting treatment and |

| |resolves on withdrawal of lamotrigine (see Special Warnings and Special Precautions for Use). |

| | |

| |Rarely, serious potentially life threatening skin rashes, including Stevens Johnson syndrome and toxic epidermal |

| |necrolysis (Lyell Syndrome) have been reported. Although the majority recover on drug withdrawal, some patients |

| |experience irreversible scarring and there have been rare cases of associated death. (See Special Warnings and |

| |Special Precautions for Use) |

| |The approximate incidence of serious skin rashes reported as SJS in adults and children over the age of 12 is 1 in|

| |1000. The risk in children under the age of 12 is higher than in adults. Available data from a number of studies |

| |suggest that the incidence in children under the age of 12 requiring hospitalisation due to rash ranges from 1 in |

| |300 to 1 in 100 (see Special Warnings and Special Precautions for Use). |

| | |

| |In children, the initial presentation of a rash can be mistaken for an infection; physicians should consider the |

| |possibility of a drug reaction in children that develop symptoms of rash and fever during the first eight weeks of|

| |therapy. |

| | |

| |Additionally the overall risk of rash appears to be strongly associated with:- |

| | |

| |High initial doses of lamotrigine and exceeding the recommended dose escalation of lamotrigine therapy (see |

| |Posology and Method of Administration). |

| | |

| |Concomitant use of valproate |

| | |

| | |

| |NetDoctor: |

| |Adverse skin reactions have been reported with lamotrigine. These reactions are usually mild and get better on |

| |their own, but can on rare occasions be more serious and potentially life-threatening. The risk is higher in |

| |children under 12 years of age and in people who are also taking the medicine valproate. When starting treatment |

| |with lamotrigine the dose is increased gradually to minimise the risk of developing a skin rash. For this reason |

| |it is very important to follow the instructions you are given with this medicine, and not to exceed the prescribed|

| |dose. If you or your child develop a rash, fever, facial swelling or swollen glands while taking this medicine you|

| |should consult your doctor immediately. If the doctor decides the reaction is related to this medicine you will |

| |need to stop taking it. |

|What advice would you give? |Rash is a common side effect of lamotrigine. It is usually red and raised and often begins within the first 8 |

|Or would you refer? |weeks of treatment. However, it can be a more serious side effect especially if there is also fever. |

| | |

| |Advise that the son sees the GP immediately or is taken to A&E. Please explain that you have phoned NHS Direct and|

| |this is what was advised. It is important that the rash be seen by a doctor and if due to lamotrigine then treated|

| |quickly. |

| | |

Workshop 4.1: Adverse Drug Reactions

|Case Scenario 3 |

|Question |My husband has recently started simvastatin and has developed muscle pain in his leg. Could it be due to this new|

| |drug? |

|What further background |PERSON |MEDICINES |

|information do you need to | | |

|clarify the question and | | |

|minimise the risks when | | |

|advising the caller? | | |

| | | |

| |Who is asking? |Medicines (name, dose, freq)? |

| |Wife about 62yr old husband. |Simvastatin 10mg once daily |

| | |Aspirin 75mg once daily |

| |New or worsening symptoms? | |

| |Muscle pain developed over last 24 hours in lower legs |How long has the patient been on these prescribed |

| |and generally feels unwell. |medications? |

| | |GP started simvastatin last week because cholesterol |

| |Any allergies/medical conditions? |level 5.7 |

| |High cholesterol |Aspirin taken for several years. |

|Gather the further background information BEFORE searching for information. |

|What information sources |eBNF: |

|would you use? |Side-effects |

| |Reversible myositis is a rare but significant side-effect of the statins (see also CSM advice (Muscle Effects), |

| |section 2.12 and below). The statins also cause headache, altered liver-function tests (rarely, hepatitis), |

| |paraesthesia, and gastro-intestinal effects including abdominal pain, flatulence, constipation, diarrhoea, nausea |

| |and vomiting. Rash and hypersensitivity reactions (including angioedema and anaphylaxis) have been reported |

| |rarely. |

| |Muscle effects Myalgia, myositis, and myopathy have been reported with the statins; if myopathy is suspected and |

| |creatine kinase is markedly elevated (more than 5 times upper limit of normal), or muscular symptoms are severe, |

| |treatment should be discontinued; in patients at high risk of muscle effects, a statin should not be started if |

| |creatine kinase is elevated. There is an increased incidence of myopathy if the statins are given at high doses or|

| |given with a fibrate (see also CSM advice), with lipid-lowering doses of nicotinic acid, or with |

| |immunosuppressants such as ciclosporin; close monitoring of liver function and, if symptomatic, of creatine kinase|

| |is required in patients receiving these drugs. Rhabdomyolysis with acute renal impairment secondary to |

| |myoglobinuria has also been reported. |

| |Counselling |

| |Advise patient to report promptly unexplained muscle pain, tenderness, or weakness. |

| |CSM advice (muscle effects) |

| |The CSM has advised that rhabdomyolysis associated with lipid-regulating drugs such as the fibrates and statins |

| |appears to be rare (approx. 1 case in every 100 000 treatment years) but may be increased in those with renal |

| |impairment and possibly in those with hypothyroidism (see also notes above). Concomitant treatment with drugs that|

| |increase plasma-statin concentration increase the risk of muscle toxicity; concomitant treatment with a fibrate |

| |and a statin may also be associated with an increased risk of serious muscle toxicity. |

| | |

| |eMC SPC- Zocor: |

| |Before the treatment All patients starting therapy with simvastatin, or whose dose of simvastatin is being |

| |increased, should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, |

| |tenderness or weakness. |

| |Whilst on treatment If muscle pain, weakness or cramps occur whilst a patient is receiving treatment with a |

| |statin, their CK levels should be measured. If these levels are found, in the absence of strenuous exercise, to be|

| |significantly elevated (> 5 x ULN), treatment should be stopped. If muscular symptoms are severe and cause daily |

| |discomfort, even if CK levels are < 5 x ULN, treatment discontinuation may be considered. If myopathy is suspected|

| |for any other reason, treatment should be discontinued. |

| |eMC PIL - Zocor |

| |Tell your doctor quickly if you experience unexplained muscle pain, tenderness or weakness. This is because on |

| |rare occasions, there is a risk of muscle problems which may be serious, including muscle breakdown which can |

| |result in kidney damage. The doctor may perform a blood test to check the condition of your muscles before and |

| |after starting treatment. |

| |Things to note regarding muscle effects |

| |The risk of muscle breakdown is greater at higher doses of ‘Zocor’. |

| |The risk of muscle breakdown is greater in certain patients. Tell your doctor if any of the following applies to |

| |you: |

| |kidney problems |

| |thyroid problems |

| |you are more than 70 years old |

| |you have ever had muscle problems during treatment with cholesterol lowering medicines called "statins" (such as |

| |simvastatin, atorvastatin, pravastatin) or fibrates (such as gemfibrozil, bezafibrate). |

| |you or close family members have a hereditary muscle disorder. |

| |The risk of muscle problems can be greater if ‘Zocor’ is taken with certain medicines |

| |NetDoctor: |

| |This medicine may occasionally have side effects on the muscles. For this reason you should inform your doctor |

| |immediately if you experience any unexplained muscular symptoms such as pain, tenderness, cramps or weakness while|

| |taking this medicine. Your doctor may need to check for side effects on the muscles by taking a blood test to |

| |measure the level of a compound called creatine kinase (CK) in your blood. If this is the case, the test should |

| |not be done following strenuous exercise. |

|What advice would you give? |Statins may have very rare side effects on muscles. |

|Or would you refer? | |

| |Advise that the husband see the GP immediately. The GP may advise that you stop this medication and may wish to |

| |do some blood test. |


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